The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™

Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™) [ Time Frame: One month after the booster dose (Month 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™) [ Time Frame: One month after the booster dose (Month 1) ] [ Designated as safety issue: No ]

Occurrence of solicited local adverse experiences [ Time Frame: During the 15-day (Day 0-14) follow-up period after vaccination ] [ Designated as safety issue: No ]

Occurrence of solicited general adverse experiences [ Time Frame: During the 15-day (Day 0-14) follow-up period after vaccination ] [ Designated as safety issue: No ]

Occurrence of unsolicited symptoms [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination ] [ Designated as safety issue: No ]

Occurrence of any serious adverse experiences [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination ] [ Designated as safety issue: No ]

Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: One month after the second and third booster dose (Month 12) ] [ Designated as safety issue: No ]

Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose ] [ Designated as safety issue: No ]

Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose ] [ Designated as safety issue: No ]

Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose ] [ Designated as safety issue: No ]

Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose ] [ Designated as safety issue: No ]

Free of obvious health problems as established by medical history and clinical examination before entering into the study

Written informed consent obtained from the subject

If the subject is female, she must be of non-childbearing potential , i.e., either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid..

Exclusion Criteria:

Vaccination against diphtheria and/or tetanus within the previous five years

Vaccination against pertussis since childhood

History of diphtheria and/or tetanus

Known history of pertussis within the previous five years

Known exposure to diphtheria or pertussis within the previous five years

Known history of non-response to diphtheria, tetanus or pertussis vaccine

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days/ 5 half-lives preceding the dose of study vaccine

Administration of chronic immunosuppressants or other immune-modifying drugs within six months/ 5 half-lives of vaccination.

Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after

Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration/ administration during the study period

Any confirmed or suspected immunosuppressive or immunodeficient condition

Pregnant or lactating female

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine

Hypersensitivity to any component of the vaccines

Acute disease at the time of enrolment

Oral temperature of ≥37.5°C (99.5°F)

Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine or diptheria and tetanus vaccines

An immediate anaphylactic reaction

Signs of encephalopathy

Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine alone or in combination with other antigens:

Rectal temperature ≥40.5°C within 48 hours of vaccination and not due to another identifiable cause

Convulsions with or without fever, occurring within 3 days of vaccination

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262924